PMA P150009S011

Device: Guardian System
Applicant: Avertix Medical, Inc.
PMA number: P150009
Supplement: S011
Product code: QBI
Decision date: 2024-01-25
Classification: Cardiovascular
Generic name: Acute coronary syndrome event detector
Approval order statement: to replacing to the Angel Medical Systems, Inc. and the AngelMed Guardian System with the Avertix Medical, Inc. Guardian System without any modification of the device and manufacture process change.

Current openFDA PMA Record#

Device: Guardian System
Applicant: Avertix Medical, Inc.
PMA number: P150009
Supplement: S011
Product code: QBI
Generic name: Acute coronary syndrome event detector
Decision date: 2024-01-25
Decision code: APPR
Date received: 2023-10-05
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: to replacing to the Angel Medical Systems, Inc. and the AngelMed Guardian System with the Avertix Medical, Inc. Guardian System without any modification of the device and manufacture process change.